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Belatacept in Renal Transplantation: Analyses Using Data From the Collaborative Transplant Study (CTS)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
University of Heidelberg
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01471223
First received: November 10, 2011
Last updated: April 12, 2012
Last verified: April 2012
History of Changes
  Purpose

The purpose of the study is to estimate the incidence rates of Post-transplant Lymphoproliferative Disorder (PTLD), malignancy and hospitalized infections in adult kidney-only transplant recipients treated with Belatacept, and compared the incidences to the incidences in those treated with Calcineurin inhibitor (CNI) based regimens at the time of transplantation.


Condition
Kidney Transplantation

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: Belatacept in Renal Transplantation: Analyses Using Data From the Collaborative Transplant Study (CTS)

Resource links provided by NLM:

Drug Information available for: Belatacept
U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Incidences of Post-transplant Lymphoproliferative Disorder (PTLD) [ Time Frame: 5 years post transplantation ] [ Designated as safety issue: Yes ]
  • Incidences of hospitalized infections [ Time Frame: 2 years post transplantation ] [ Designated as safety issue: Yes ]
  • Incidences of malignancy [ Time Frame: 5 years post transplantation ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Incidence rates of PTLD in adult subgroups of Belatacept- vs. CNI-treated, kidney-only transplant recipients defined by donor-recipient Epstein Barr virus (EBV) serostatus and by age groups [ Time Frame: Every 6 months and 12 months ] [ Designated as safety issue: Yes ]
  • Location, mortality, and tumor type of all PTLD cases in adult kidney-only transplant recipients treated with Belatacept vs. CNI-based regimens at the time of transplantation and in subgroups of these transplant recipients [ Time Frame: Every 6 months and 12 months ] [ Designated as safety issue: Yes ]
    Subgroups of the transplant recipients defined by donor-recipient EBV serostatus at the time of transplantation

  • Cumulative incidence of hospitalized infections in adult kidney-only transplant recipients treated with Belatacept vs. CNI-based regimens at the time of transplantation [ Time Frame: Every 6 months and 12 months ] [ Designated as safety issue: Yes ]

    Hospitalized infections for the following infection groups:

    1. Bacterial
    2. fungal
    3. Viral
    4. Tuberculosis
    5. Herpes and
    6. Cytomegalovirus (CMV)

  • Incidence rates of graft rejection in adult kidney-only transplant recipients treated with Belatacept vs. CNI-based regimens at the time of transplantation [ Time Frame: Every 6 months and 12 months ] [ Designated as safety issue: Yes ]
  • Incidence rates of graft failure in adult kidney-only transplant recipients treated with Belatacept vs. CNI-based regimens at the time of transplantation [ Time Frame: Every 6 months and 12 months ] [ Designated as safety issue: Yes ]
  • Mortality rate of composite bacterial, fungal, viral, tuberculosis, herpes, and CMV infections [ Time Frame: 2 years post transplantation ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 5000
Study Start Date: April 2012
Estimated Study Completion Date: February 2021
Estimated Primary Completion Date: February 2021 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients receiving Belatacept in CTS
Patients receiving a 1st kidney-only transplant at a center participating in the CTS and receiving Belatacept at the time of transplantation
Patients receiving CNI in CTS
Patients receiving a 1st kidney-only transplant at a center participating in the CTS and receiving CNI at the time of transplantation

Detailed Description:

Time Perspective: Prospective design, Retrospective data collection and analysis

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients undergoing 1st kidney only transplantation, whose transplant centers participate in CTS and who are treated with Belatacept or a CNI based regimen at the time of transplantation

Criteria

Inclusion Criteria:

  • 1st kidney only transplant during study, at one of the transplant centers participating in CTS, received Belatacept or a CNI at the time of transplantation

Exclusion Criteria:

  • Patients with a history of malignancy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01471223

Sponsors and Collaborators
Bristol-Myers Squibb
University of Heidelberg
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
BMS Clinical Trials Disclosure  This link exits the ClinicalTrials.gov site
Investigator Inquiry form  This link exits the ClinicalTrials.gov site
FDA Safety Alerts and Recalls  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01471223     History of Changes
Other Study ID Numbers: IM103-089
Study First Received: November 10, 2011
Last Updated: April 12, 2012
Health Authority: European Union: European Medicines Agency

Additional relevant MeSH terms:
Abatacept
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions
 Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2013